Product Formulation Technician - Solutions

The Ritedose Corporation; Columbia (SC); On-site; USD 42,000 - 64,000; Full time

Job summary

The Ritedose Corporation is seeking a Product Formulation Technician to operate compounding equipment in both the Commercial and Development formulation areas. You will follow cGMP guidelines, execute batch compounding, and keep accurate documentation in TRC records.

You will also assist with SOPs, calibration, cleaning, and cross-training with the Dispensing Department, contributing to safe, compliant formulation processes across multiple product lines.

Qualifications

• High School diploma or GED.
• 0-2 years experience in a regulated laboratory environment.
• Knowledge of cGMP Guidelines.
• Ability to participate and develop a team-oriented working relationship.
• Ability to prioritize task with minimal supervision.
• Must possess very good oral and written communication.

Responsibilities

• Operate compounding equipment in both Commercial and Development areas according to procedures.
• Assist in establishing SOPs and ensuring calibration and cleaning requirements are met.
• Maintain a clean, safe, and orderly staging, dispensing, and compounding area.
• Assist in sampling and weighing of chemicals required for product formulation.
• Perform validation methods on compounding equipment and routine maintenance.
• Perform filter testing on sterile filters and maintain logbooks.
• Responsible for batch compounding and documentation per TRC protocols.
• Handle pre/post cleaning and steaming of equipment, and cross-train with Dispensing.
• Follow SOPs and cGMP guidelines related to safety and health.

Skills

Teamwork

Prioritization

Communication

cGMP knowledge

Education

High School diploma or GED

Job description

The Product Formulation Technician is responsible for operating compounding equipment and may be required to work in both the Commercial formulation area, as well as, the Development formulation area. Responsibilities also include following necessary methods and procedures to produce a functional compounding process. The Product Formulation Technician ensures that documentation and activities in the compounding area are compliant with any applicable regulations.

Commercial Responsibilities

• Assist the Aseptic Processing Manager in establishing SOPs as needed.
• Satisfy the compounding equipment operation, calibration, and cleaning requirements.
• Keep a clean, safe, productive, and orderly staging, dispensing, and compounding area.
• Assist in sampling and weighing of chemicals required to support product formulation.
• Perform validation methods on the compounding equipment.
• Perform filter testing on sterile filters and maintain logbooks.
• Responsible for batch compounding according to TRC Documents and Protocols.
• Responsible for the pre and post cleaning and steaming of the compounding equipment.
• Perform routine maintenance on equipment.
• Responsible for cross-training with the Dispensing Department.
• Follow SOPs safety, health and cGMP guidelines.

Development Responsibilities

• Assist the Product Development Engineer in developing safe and efficient functional procedures and work instructions in support of new formulation processes.
• Operate equipment in the formulation of new products and new processes to support formulation and equipment studies, and validation activities.
• Perform the sampling of raw materials when necessary and obtaining the tools and instruments required to support operation of the process.
• Formulate GMP Development Batches for Validations, Clinical Distribution and FDA Regulatory filings in compliance with TRC Batch Record instructions, Procedures and Policies.

Physical Requirements

• Ability to push and pull extremely heavy tanks and lift and carry up to 40 pounds of equipment, parts or supplies.
• Ability to wear a respirator.
• Ability to stand while working for 12 hour shifts.

Qualifications

• High School diploma or GED
• 0-2 years experience in a regulated laboratory environment
• Knowledge of cGMP Guidelines
• Ability to participate and develop a team-oriented working relationship
• Ability to prioritize task with minimal supervision
• Must possess very good oral and written communication